Early Amniotomy After Vaginal Prostaglandin E2 for Induction of Labor at Term: a Randomized Clinical Trial
This trial has been completed.
|Condition||early amniotomy, unfavorable cervix|
|Sponsor||Zeynep Kamil Maternity and Pediatric Research and Training Hospital|
|Start date||August 2016|
|End date||October 2016|
|Trial size||200 participants|
|Trial identifier||NCT02856724, 145|
This study evaluates the effectiveness and safety of early amniotomy after vaginal prostaglandin E2 for induction of labor at term. Early amniotomy will be done in the early active phase of labor for early amniotomy group ( half of participants) when the cervix will dilated 3 cm using the amniotomy hook. Amniotomy will not be done for control group(other half of participants) until the membranes rupture spontaneously.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
induction-to- delivery time
time frame: delivery (the length of time between the beginning of induction and the end of labor)
mode of labor (vaginal or C-section)
time frame: delivery
time frame: vaginal delivery within 24 h from the beginning of induction
Female participants from 18 years up to 40 years old.
Inclusion criteria 1. singleton pregnancy, 2. gestational age ≥34 weeks, 3. intact membranes, 4. cephalic presentation, 5. bishop score ≤5, 6. had obstetrical indications for induction of labor, 7. had less than three uterine contractions in every 10 minutes. Exclusion Criteria: 1. Patients who have contraindications for vaginal delivery, 2. previous uterine surgery, 3. fetal malpresentation, 4. multifetal pregnancy, 5. more than three contractions in 10 minutes, 6. contraindications to prostaglandins, 7. a category II or III fetal heart rate pattern, 8. anomalous fetus, 9. fetal demise 10. women with immediate delivery indications -
|Description||During induction of labour, amniotomy (defined as artificial rupture of fetal membranes) is commonly used in combination with induction of labor. However, there is a lack of data on both effectiveness and ideal timing of this procedure. Yet for patients with an unfavorable cervix, a sharply ripening agent may be considered. As is well known to all,prostaglandin works efficiently in cervical ripening and labor induction. So dinoprostone surely performs quite well in promoting cervical ripening and labor induction since its main component is prostaglandin E2 (PGE2).|
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